MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Model Number	400SMTXSFT1H02
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.The pusher assembly had kinks and bends along its length.The pull wire was retracted from the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned smart coil confirmed that the embolization coil was detached from the pusher assembly and revealed that the pet lock was broken on the proximal end of the pusher assembly.If the pet lock is mishandled while the smart coil is manipulating against resistance, the pet lock may break.If the pet lock is broken, and the pull wire is retracted from the ddt, the embolization coil may detach from its pusher assembly.Further evaluation of the device revealed kinks and bends on the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was reported that the patient anatomy was tortuous.During the procedure, while advancing a smart coil through the microcatheter, the physician experienced resistance.Subsequently, the physician attempted to push the smart coil, but the smart coil unintentionally detached in the microcatheter.The microcatheter containing the detached smart coil was removed.The procedure was completed using a non-penumbra coil and a new microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10872199
• Report Number: 3005168196-2020-02045
• Device Sequence Number: 16774664
• Product Code: HCG
• UDI-Device Identifier: 00814548015224
• UDI-Public: 00814548015224
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2021
• Device Model Number: 400SMTXSFT1H02
• Device Catalogue Number: 400SMTXSFT1H02
• Device Lot Number: F70012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005